🏥FDA Pediatric Advisory Committee Meeting Notice for Public Comments
The Food and Drug Administration (FDA or the Agency) announces a forthcoming public advisory committee meeting of the Pediatric Advisory Committee (PAC). The general function of the committee is to provide advice and recommendations to FDA on pediatric regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Learn More🦠FDA Classifies Fungal Nucleic Acid Detection Device to Class II
The Food and Drug Administration (FDA, Agency, or we) is classifying the device to detect and identify fungal nucleic acids directly in respiratory specimens into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the device to detect and identify fungal nucleic acids directly in respiratory specimens' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Learn More🧬FDA Proposes Reclassification of Hematology Devices Affecting ISH Systems
The Food and Drug Administration (FDA) is proposing to reclassify in situ hybridization (ISH) test systems indicated for use with a corresponding approved oncology therapeutic product (product codes NYQ, MVD, OWE, and PNK) from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation, along with the special controls that FDA believes are necessary to provide a reasonable assurance of safety and effectiveness for this device type.
Learn More💊FDA Seeks Input on Medical Device User Fee Amendments Reauthorization
The Food and Drug Administration (FDA, the Agency, or we) is hosting a hybrid public meeting entitled "Medical Device User Fee Amendments." The purpose of the public meeting is to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years (FYs) 2028 through 2032. MDUFA authorizes FDA to collect fees and use them for the process for the review of device applications. The current legislative authority for MDUFA expires September 30, 2027. At that time, new legislation will be required for FDA to continue collecting device user fees in future fiscal years. The Federal Food, Drug, and Cosmetic Act (FD&C Act) directs that FDA begin reauthorization by publishing a notice in the Federal Register requesting public input and holding a meeting where the public may present its views on the reauthorization. FDA invites public comment as the Agency begins the process to reauthorize the program in FYs 2028 through 2032. These comments will be published and available on FDA's website.
Learn More💼FDA Notice on Medical Device User Fee Small Business Certification
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Learn More📄FDA Announces M11 Technical Specification for Clinical Trials
The Food and Drug Administration (FDA or Agency) is announcing the availability of the revised draft technical specification entitled "M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol (CeSHarP)" and a supplemental document entitled "M11 Template." The revised draft technical specification and template were prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The revised draft technical specification recommends the use of an open, nonproprietary standard to enable electronic exchange of clinical protocol information. The template identifies headers, common text, and a set of data fields and terminologies that will be the basis for efficiencies in data exchange. These ICH documents create an international standard for the content and exchange of clinical trial protocol information facilitating review and assessment by regulators, sponsors, ethical oversight bodies, investigators, and other stakeholders. This revised draft technical specification and updated template revise and replace the draft versions of the same titles issued in December 2022.
Learn More📦FDA Draft Guidance on Hernia Mesh Package Labeling Recommendations
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Hernia Mesh--Package Labeling Recommendations." This draft guidance provides labeling recommendations for hernia mesh devices that are intended to help promote the safe and effective use of hernia mesh. This draft guidance is not final nor is it for implementation at this time.
Learn More📋FDA Releases Guidance on Raw Data Submission for Animal Drugs
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #287 entitled "Raw Data for Safety and Effectiveness Studies." This guidance provides information to animal drug sponsors (sponsors) on the use of raw data in the Center for Veterinary Medicine's (CVM) review of safety and effectiveness studies submitted in support of new animal drug applications. This guidance also describes our recommendations for submitting raw data.
Learn More📄FDA Draft Guidance on 510(k) Clearance Transfer Available
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Transfer of a Premarket Notification (510(k)) Clearance--Questions and Answers." This guidance provides information on the most frequently asked questions regarding transfer of ownership from one 510(k) holder to another. This draft guidance is not final nor is it for implementation at this time.
Learn More💊FDA Draft Guidance on OTC Monograph Minor Changes Available
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry titled "Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs." The purpose of this guidance is to provide recommendations for how requestors can comply with the requirements described in the Proposed Administrative Order (OTC000038) titled Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs (hereinafter referred to as C001).
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